CSV Validation Engineer — GMP IT/OT for Biotech

RoviSys; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

RoviSys partners with biotech and pharmaceutical manufacturing clients to deliver automation, IT/OT integration, and computer system validation services.

The CSV Engineer supports client CSV strategy and validation activities for automation and IT/OT products deployed on client sites, including local software instance qualification for global/core systems (e.g., MES), local vendor product software qualification, and IT infrastructure (servers, workstations, network switches).

Qualifications

• Diploma or B.S. in Computer Science, Chemical Engineering, Electrical Engineering, or equivalent.
• Experience with IT/Automation system support in biotech GMP environments.
• Familiarity with CSV activities.
• Strong team player in a client-facing environment.
• Self-driven with strong verbal and written communication.
• Familiar with AVEVA PI or MES is a plus.

Responsibilities

• Generate CSV deliverables for product software and IT infrastructure during automation projects.
• Collaborate with client IT/OT, Quality, MSAT/Automation, Manufacturing, and QC teams on assessments.
• Manage and maintain lifecycle documentation for validated systems.
• Author protocols for commissioning and qualification activities.
• Ensure work adheres to client quality policies, GxP, and SOPs.
• Apply GEP principles to validation and commissioning work.
• Comply with client site and RoviSys SHE requirements and report hazards.
• Observe site security protocols and report suspicious activity.
• Drive continuous improvement with Lean tools in validation and project delivery.

Skills

CSV activities

Team collaboration

Communication

Self-driven

Education

Diploma or B.S. in Computer Science, Chemical Engineering, Electrical Engineering, or equivalent

Tools

AVEVA PI

MES

Job description

RoviSys partners with biotech and pharmaceutical manufacturing clients to deliver automation, IT/OT integration, and computer system validation services.

The CSV Engineer supports client CSV strategy and validation activities for automation and IT/OT products deployed on client sites, including local software instance qualification for global/core systems (e.g., MES), local vendor product software qualification, and IT infrastructure (servers, workstations, network switches).